Nicotinamide in the Treatment of Psoriasis

Isfahan University of Medical Sciences

Status and phase: Completed; Phase 3; Phase 2

Conditions: Psoriasis

Treatments: Drug: Calcipotriol plus Nicotinamide; Drug: Calcipotriol

Study type: Interventional

Funder types: Other

Identifiers

NCT01763424

390134

Details and patient eligibility

About

This study will determine if combination of topical calcipotriol and nicotinamide is more effective than calcipotriol alone in treatment of psoriasis.

Full description

Current treatment strategies of psoriasis are not completely satisfactorily. By inhibiting inflammatory cytokines, nicotinamide may enhance the effects of current topical treatments. Preliminary studies have shown that nicotinamide, which is a vitamin B derivative, is effective in the treatment of psoriasis. According to lack of data, we will investigate the beneficial effects of adding nicotinamide to calcipotriol for patients with mild to moderate psoriasis.

Enrollment: 66 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and women of 18 to 65 years old,
• Mild to moderate psoriasis; patients must have had less than 15% of the involved body surface, symmetrical plaques (bilateral lesions) or two plaques at least 5 cm apart on the same side of the body with plaque size greater than 2 × 2 cm, but smaller than 15 × 15 cm.
• Willingness to participate

Exclusion criteria

• Those who used any medication or niacin and multi-vitamins two weeks, or anti-psoriatic systemic drugs or beta-blockers one month prior to the study,
• Pregnant women,
• Those with the history of renal, hematologic, liver and major psychiatric diseases,
• Those with only scalp, nail, flexural, palmoplantar, or pustular psoriasis.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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66 participants in 2 patient groups

Calcipotriol

Active Comparator group

Description:

Patients applied calcipotriol 0.005% (By LEO Pharmaceuticals, Ballerup, Denmark) for lesions of the other side of the body. The patients uses the medications twice daily (in the morning and before sleeping) for 12 weeks; the total doses of medication used not more than 100 gram per week.

Treatment:

Drug: Calcipotriol

Calcipotriol plus Nicotinamide

Experimental group

Description:

Patients applied calcipotriol 0.005% and nicotinamide 4% in combination (By LEO Pharmaceuticals, Ballerup, Denmark) for lesions of one side of the body. The patients uses the medications twice daily (in the morning and before sleeping) for 12 weeks; the total doses of medication used not more than 100 gram per week.

Treatment:

Drug: Calcipotriol plus Nicotinamide